Kornimate/medical-research-clean huggingface dataset:
evalution of optical enhancement with magnification for polyop histology

Conditions: Colorectal Polyps

Summary: when a polyp is found, it woulf be recorded by a white-light and oe1 model with magnification for assessing and predicting its histology. after that, its really histology will be reported by an pathologist. when a polyp is found, oe mode 1 with magnification was first used with near focus the polyp and an endoscopist made a real-time prediction of polyp pathology. after that, high-definition mode and oe mode 1 without magnification were used to observe polyp sequencely. the video of all procedure was recorded.

after bowel cleansing with 2l polyethylene glycol, patients received colonoscopy under propofol intravenous anesthesia. when a polyp was found, we began to wash it and record the video. oe mode 1 with magnification was first used with near focus the polyp and an endoscopist made a real-time prediction of polyp pathology. after that, high-definition mode and oe mode 1 without magnification were used to observe polyp sequencely. biopsy of the polyps were taken after observation, and the size of polyps was estimated by the biopsy forceps. the information of patient age, gender polyp morphology and location were recorded. after a video transcoding and clipping, the pathology type of each video clip was predicted by an endoscopist. the sensitivity, specificity, positive predicting value (ppv), negative predicting value (npv) and accuracy were calculated. the pathology types of polyps were classified by non-neoplastic polyps and neoplastic polyps according to vienna classification. statistics were performed by ncss 11 and r software (version 3.3.2).

Eligibility criteria:
inclusion criteria: * patients will be included if they are found polyps during endoscopy procesure. exclusion criteria: * inflammatory bowel disease * biopsies were not available. * unable to provide informed consent.

Keywords: optical enhancement technology coloractal polyp prediction
two-stage treatment of large bone defects with cerament® g and cerament® v plus auto and/or allograft using the masquelet technique as salvage therapy after bone resection in patients with septic pseudarthrosis

Conditions: Pseudarthrosis

Summary: septic pseudarthrosis of long bones are complications that can unfortunately occur after the consolidation of a fracture and some situations present risks of superinfection, persistent infection or mechanical failure (30-40% risk of complications) that can lead to amputation. a possible saving situation used by crioac ("centre de référence des infections ostéo-articulaires complexes") is the use of a bone substitute impregnated with an antibiotic allowing a high local concentration of this antibiotic. the aim of this study is to evaluate the cost of management of septic pseudarthrosis with two-stage treatment and cerament® and the quality of life for this patients.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years old * diagnosis of septic pseudarthrosis * septic pseudarthrosis managed by the surgical technique using the cerament bone substitute combined with an autograft / allograft by the masquelet technique or, for the comparative cohort: septic pseudarthrosis on long bone previously managed by the masquelet method without cerament® * medico-surgical management within the crioac ("centre de référence des infections ostéo-articulaires complexes") of the croix-rousse hospital in lyon * patient who was informed and did not object to participate in the study exclusion criteria: * patient with a disability (deafness, language disorders) or whose mental or cognitive state does not allow to be informed and to express his opposition if necessary. * patient with a disability (deafness, language impairment) or whose mental or cognitive state does not allow to understand the questions in the quality of life questionnaire * patient participating in another quality of life study
generic tacrolimus in the elderly - prograf® vs tacni®

Conditions: End Stage Renal Disease

Summary: test bioequivalence of generic tacrolimus (tacni), using original tacrolimus (prograf) as comparator, in elderly (\>60 yr) renal transplant recipients

12-hour pharmacokinetic investigations performed on each formulation in each patient at steady-state. patients will be randomized with regards to which formulation to start with. 1-2 weeks between each pk investigation.

Eligibility criteria:
inclusion criteria: * renal transplant recipients that will receive tac as part of their immunosuppressive therapy. * recipients 60 years of age or older. * signed informed consent. exclusion criteria: * diabetes mellitus (who criteria). * concomitant treatment with: diltiazem, verapamil, phenytoin, carbamazepin, fluconazole, ketoconazole, voriconazole, erythromycin, clarithromycin.

Keywords: renal transplantation elderly
ucla fitness and memory study of activity in mild cognitive impairment (aim)

Conditions: Mild Cognitive Impairment

Summary: this project will examine the relationship between physical activity levels, brain structure and memory function in adults with mild cognitive impairment (mci) aged 60 to 75. the study will follow 30 adults with age-associated memory impairment or mci over the course of 18 months. during this time, subjects' physical activity levels will be measured regularly and related to both the thickness their hippocampus and to their memory performance. subjects will be recruited and screened for major health problems at ucla. physical activity will be tracked for two weeks using accelerometers at baseline and every 6 months during the study. at baseline and at the end of the study, subjects will undergo a structural mri brain scan to measure hippocampal thickness, as well as a neuropsychological evaluation to measure memory function. the study will seek to determine the relationship between physical activity level, hippocampal thickness and memory performance in older adults with age-associated memory impairment.


Eligibility criteria:
inclusion criteria: * agreement to participate in the study * 60-89 years of age * diagnostic criteria for mild cognitive impairment diagnosis: subjective memory complaints, montreal cognitive assessment score of \<26, intact instrumental activities of daily living (smith et al., 1996) or subjective age-associated memory complaints * cohabitation with an adult capable of ensuring correct usage of the physical activity monitors during the study and verifying self-reports of activity levels. * adequate visual and auditory acuity to allow neuropsychological testing. * screening laboratory tests and ekg without significant abnormalities that might interfere with the study. if screening laboratory tests or ekg show abnormalities, pi may request clearance from primary care physician before subject continues in study. exclusion criteria: * comorbid conditions impacting mobility * current, untreated depression: bdi-ii score \>13 * diagnosis of probable alzheimer's disease (ad) or any other dementia (e.g., vascular, lewy body, frontotemporal). * evidence of other neurological or physical illness that can produce cognitive deterioration. volunteers with a history of head trauma, stroke, tia, carotid bruits, or lacunes on mri scans will be excluded. * contraindication to the mri including claustrophobia, metal in body, surgery within 60 days, certain medical implants or previous abnormal mri results. * history of cardiovascular disease * uncontrolled hypertension (systolic bp \> 170 or diastolic bp \> 100) * current diagnosis of any major psychiatric disorder according to the dsm-iv tr criteria (apa, 2000), including current alcoholism or substance addiction. * current use of marijuana * previous use of marijuana for at least 15 days in a month, initiating use during adolescence and continuing for at least one year

Keywords: physical activity, aging, memory, cognitive impairment, mri, neuroscience
evaluation of liquid vs. tablet buprenorphine - 6

Conditions: Opioid-Related Disorders

Summary: the purpose of this study is to evaluate the steady-state pharmacokinetics and bioavailability of buprenorphine sublingual tablets vs. sublingual solution.


Eligibility criteria:
inclusion criteria: m/f ages 21-50. meet dsm-iv criteria for opioid dependence. agree to conditions of the study and sign informed consent. exclusion criteria: psychiatric disorder that requires medication therapy. history of seizures. pregnant and/or nuring women. dependence on etoh or benzodiazepines or other sedative/hypnotics. acute hepatitis. other medical condtions that deem participation to be unsafe.

Keywords: opioid dependence
hydrogen inhalation for health and exercise performance

Conditions: Exercise Performance

Summary: in this randomized double-blind, placebo-controlled, crossover pilot trial, we evaluated the effects of 7-day h2 inhalation on exercise performance outcomes and serum hormonal and inflammation profiles in a cohort of young men and women.

all participants were allocated to receive either gaseous hydrogen (4%) or placebo (room air) by 20-min once-per-day inhalation for 7 days, with wash-out period of 7 days to prevent the residual effects of interventions across study periods. the primary treatment outcome was the change in running time-to-exhaustion from baseline to day 7. additionally, assessment of other exercise performance endpoints and clinical chemistry biomarkers were performed at baseline and after 7 days after each intervention.

Eligibility criteria:
inclusion criteria: age ≥ 18 -35 years body mass index 20 - 25 kg/m2 free of major diseases physically active must be able to give written informed consent exclusion criteria: use of any dietary supplements within 4 weeks before study commences abnormal values for lab clinical chemistry (\> 2 sd)
benefits of a cannabidiolic acid topical cream for the treatment of restless leg syndrome

Conditions: Restless Legs Syndrome

Summary: the goal of this open label clinical trial is to reduce the effects of restless leg syndrome. the main it questions it aims to answer are: 1. reduce or eliminate the symptoms of restless leg syndrome. 2. improve the quality of life of participants with restless leg syndrome. participants will be asked to apply the topical cream to the affected area 30 to 45 minutes before bedtime for 14 consecutive days.

restless leg syndrome (rls) is multifactorial disease state with many different potential pathophysiological mechanisms, which includes dysfunctions from the cerebral cortex and spinal cord to mechanosensitive channels at the musculoskeletal periphery.1 most therapeutic agents' effectiveness focuses on the cns (e.g., dopaminergic drugs) or renshaw cells. to our knowledge, therapeutic agents that are focused on the periphery were not very effective. this technology focuses on the peripheral musculoskeletal component of the disease and is directed at treatment modalities that correct the dysfunction of mechanosensitive channels. by combining what is known about cannabinoids activity at the transient receptor potential channel of ankyrin 1 (trpa1)2 and the role trpa1 plays in regulating the shape and rigidity of the surrounding membrane structure at the piezo channels3, an effective therapy at the site of discomfort should emerge. moreover, the lessening of membrane tension is imparted by molecules that readily penetrate the membrane4, which chylobinoid, the topical active ingredient, is uniquely designed to do.

Eligibility criteria:
inclusion criteria: * patients with at least 3 month-course of symptomatic restless leg syndrome * must meet international restless legs syndrome study group (irlssg) criteria of at least mild symptoms. * age \> 18 years, including both males and females * patient provides informed consent exclusion criteria: * previous operative procedure for treatment of rls; * current use of tens (transcutaneous electrical nerve stimulation or plasma exchange; * allergy to cannabidiol (cbd) cannabidiolic acid (cbda), or any other ingredient contained in the topical cream; * pregnant participants (participants who have the potential for being pregnant will sign a waiver), or breast feeding; * history of recreational substance abuse, fibromyalgia, chronic regional pain syndrome (crps), psychiatric history including but not limited to schizoaffective disorder, bipolar disorder, chronic depression, and suicidal ideation; * conditions affecting capacity and adherence to study regimen including but not limited to dementia/delirium, alzheimer's, down's syndrome; * a need for elective surgery involving preoperative or postoperative analgesics or anesthetics during the study period; * no recent cannabinoid use in the last 2 months, and no use during the study.
cone-beam ct guided stereotactic radiation therapy for locally advanced pancreatic cancer

Conditions: Pancreatic Cancer

Summary: pancreatic cancer has a very poor survival, due to late diagnosis and lack of sufficient treatment options for locally advanced tumors and metastasized patients. high dose radiotherapy with small margins seems feasible with current technical possibilities, e.g. by fiducial guided stereotactic radiotherapy. in this study, we want to evaluate safety and technical feasibility for cone beam ct guided stereotactic radiotherapy for locally advanced pancreatic carcinoma.

objective of the study: to determine safety and technical feasibility of stereotactic radiotherapy for locally advanced pancreatic carcinoma study design: pilot study to determine safety and feasibility study population: patients with locally advanced pancreatic carcinoma, without distant metastasis intervention: patients will undergo endoscopic fiducial marker placement, and patients will get a custom-made individual corset. radiotherapy will be delivered in three fractions of 8 gy on an outpatient basis. primary study outcome: the main study endpoint will be safety of the procedure, expressed in proportion of patients experiencing treatment-induced toxicity grade 3 or more according to the ctc-ae 4.0 due to the complete procedure within 90 days of the last radiation. secondary study outcome: other study parameters will be technical feasibility, treatment response, quality of life, overall survival, progression free survival, and rate of possible secondary resections nature and extent of the burden and risks associated with participation, benefit and group relatedness: increased severe toxicity may occur due to the intervention, but treatment related toxicity should be limited due to strict dose constraints to the organs at risk (e.g. duodenum, stomach). potential benefits may be pain relief, due to local control of the tumor, and a prolonged survival.

Eligibility criteria:
inclusion criteria: * locally advanced pancreatic tumors (stage iii) or medically inoperable patients with pancreatic cancer (stage i, ii, or iii) * not eligible for operation with curative intent * \>18 years * written informed consent exclusion criteria: * who performance status 3-4 * expected life span \<3 months * previous chemotherapy, pancreatic surgery or pancreatic radiotherapy * exclusion criteria for contrast enhanced mri and/or ct scan, following the protocol of the department of radiology umcu

Keywords: pancreatic cancer radiotherapy sbrt
synrinse irrigation pilot (sip) trial

Conditions: Sinusitis, Chronic; Cystic Fibrosis With Other Manifestations

Summary: assess if the use of synrinse can improve short-term subjective and objective outcome measures after one week in patients with active chronic rhinosinusitis (crs) who have had prior sinus surgery.

synrinse is osmotically balanced and also contains soluble chitosan-argininamide, a modified natural glycopolymer that has a number of properties important to relieving the symptoms of mucus build up and bacterial biofilms. first, synrinse reduces the viscosity of biofilms, the protective environment of infective bacteria that prevents topical antibiotics and other rinses to penetrate to reach the bacterial. by disrupting biofilms, synrinse allows them to be cleared from the sinuses. second, synrinse has been shown to interact with the polymers comprise mucus, loosening thick, sticky layers and reducing their ability to adhere together and to mucosal surfaces. third, all of the components in synrinse are biocompatible and soothing to sensitive nasal cavities.

Eligibility criteria:
inclusion criteria: * age \>= 18 * meet diagnostic criteria for crs (as defined by the aao-hns 2015 clinical practice guidelines for adult sinusitis). * have undergone at least one functional endoscopic sinus surgery, be at least 6 weeks out from surgery, be free of any complication from surgery, and have patent sinuses confirmed by nasal endoscopy. * have active sinus disease as defined as purulent sinus discharge visualized on nasal endoscopy. * have more than mild symptoms as determined by the snot-22 with a score \>20. * be willing to hold off on standard therapy for chronic sinusitis for 1 week including oral antibiotics and/or oral steroids. * if on topical steroids for greater than 1 month (sprays, drops, or irrigation) these will be continued based on the patients' current use (continued if they are already on them, not initiated if they are not on them). * must be able to irrigate with large volume/low pressure nasal lavage throughout the study. exclusion criteria :• have an allergy to shell fish. * be able to return for follow up evaluation in 1 week (+ up to 5 days if needed) * have obstructive nasal polyps * participants who have used topical antibiotics within 4 weeks of treatment or are actively using them and unwilling to stop * participants who have used systemic steroids within 4 weeks of treatment * are unable to give informed consent or complete self-administered questionnaires written in english because of cognitive impairment, language barrier, or severe medical conditions. * have a terminal illness or significant immune dysfunction. * have severe or emergent complications from crs or presence of a sinus tumor. * patients with cystic fibrosis will be recruited in a parallel study. * participants who are unwilling to discontinue other sinus irrigations treatments and steroid lavage if already on them (including baby shampoo, surfactant, colloid silver, manuka honey, iodine, alcohol, tea tree oil, or any other compound).

Keywords: chronic rhinosinusitis (crs), cystic fibrosis related crs
national survey concerning vaccination against covid-19 in nursing homes and long-term care units

Conditions: SARS-CoV-2; Covid19

Summary: the covid-19 pandemic is a challenge for the french healthcare system, particularly among the elderly due to their particular vulnerability to the serious consequences of the disease, with an estimated mortality rate of around 30-35% among the frail elderly. the management of the health crisis could take a new turn in 2021 with the arrival in france of vaccines against the sars-cov-2 virus. the objectives of this vaccination campaign are to reduce the morbi-mortality attributable to covid-19 on the one hand, and to maintain essential activities related to the functioning of the country on the other hand and in particular the health system. however, the distrust of vaccination, traditionally strong in france, could have a negative impact on this strategy. while the president of the republic announced on november 24, 2020 that vaccination against sars-cov-2 would not be made compulsory, almost one french person in two declared in several surveys that they did not want to be vaccinated; the main criterion for acceptance of vaccination being advanced age (the older they are, the more french people declare accepting to be vaccinated). in view of the gradual vaccine supply schedule for the year 2021, the french national authority for health established at the end of 2020 a prioritization by vaccine availability phases. the critical initial supply phase,which is currently taking place, is the one during which residents of retirement home and long-term care units are prioritized because of their particular vulnerability (age and co-morbidities) and their increased exposure to sars-cov-2. for these reasons, and in order to carry out the current vaccination campaign in the most optimal way possible, this national survey is launching to evaluate the acceptance rate of the sars-cov-2 vaccine among people living in retirement homes and long-term care units, to understand the mechanisms of acceptance or rejection, and to draw up an initial large-scale inventory of the symptoms observed following vaccination.


Eligibility criteria:
inclusion criteria: * people aged 75 years and older in retirement homes or long-term care units who have accepted the sars cov-2 vaccine * people aged 75 years and older in retirement homes or long-term care units who have refused the sars cov-2 vaccine * national survey in france exclusion criteria: * opposition of the elderly person and/or his or her relatives
the effect of sodium reduction on blood pressure and physical function in older adults

Conditions: Hypertension; Physical Disability; Aging

Summary: this study will examine the effects of low sodium meal plan on seated blood pressure in older adults from a community-based, congregate senior living facility.

hypertension in older adults is a known contributor to both cardiovascular disease and falls. the centers of disease control advocates for low sodium, senior meal plans as a strategy to lower blood pressure (bp). however, sodium is recommended to treat orthostatic hypotension (oh), a risk factor of falls. the long-term effects of low sodium intake on physical function are largely unknown in older adults. the objective of this proposed pilot study is to determine the feasibility of an individual-level, randomized feeding study that examines the impact of sodium reduction on bp regulation among 40 semi-independent, older adults aged 60 and above. primary aim 1: to determine the effects of a low sodium (\<0.9 mg per kcal of energy intake), 2-week meal plan compared with a usual meal plan (average sodium \~2 mg per kcal of energy intake) on seated bp among independently living older adults. hypothesis aim 1: compared with the usual meal plan, a reduced sodium meal plan will lower seated bp in older adults after 2 weeks. feasibility aim 1: to evaluate the recruitment experience, meal cost, meal delivery logistics, and compliance with and tolerability of the meal plan (urine sodium and palatability questionnaires). feasibility aim 2: to determine effect size (variance) of secondary outcomes: standing bp, oh (standing minus seated bp), orthostatic symptoms, and a timed up and go test (tug). eligible participants will be randomized to low versus usual sodium meal plans for two weeks. assessments will be made at the in-person baseline visit, one week telephonic interview and 2 week in person follow-up visit. the primary outcome is seated bp and secondary outcomes include orthostatic hypertension and timed up and go (tug) tests. both primary and secondary outcomes will be measured twice: (1) before the study begins (baseline), and (2) after 2 week period. patient-reported outcomes, dietary compliance, and urine electrolytes will be assessed as well. intent-to-treat analysis will be conducted for all endpoints.

Eligibility criteria:
inclusion criteria: * resident at jack satter house in revere * age \>= 60 years * resting systolic blood pressure 100-149 mm hg and diastolic blood pressure \<100 mm hg * stable bp medications (no recent or intended changes) exclusion criteria: * cognitive impairment (montreal cognitive assessment test \<18) * unstable blood pressure medications in the past 2 months * terminal or mental illness * severe allergies to common foods * unwillingness to comply with the diet * physical inability to do a timed up and go test * active kidney dialysis or history of kidney transplant

Keywords: sodium intake blood pressure hypertension physical function older adults randomized controlled trial